Bausell R Barker, Lee Wen-Lin, Soeken Karen L, Li Yu-Fang, Berman Brian M
University of Maryland School of Nursing, Baltimore, MD 21201, USA.
J Clin Epidemiol. 2004 May;57(5):438-46. doi: 10.1016/j.jclinepi.2003.11.001.
To determine if the quality of complementary and alternative medicine (CAM) placebo controlled randomized controlled trials (RCTs) is related to the effect sizes they produce when the type of interventions and outcome variables are controlled.
A sample of 25 CAM meta-analyses was identified from MEDLINE and hand searches containing published effect sizes for at least three efficacy trials employing placebo control groups. From these 25 reviews, 26 pairs of trials were selected: the one reporting the largest effect size and the matching trial reporting the smallest effect size. Quality and publication characteristics were then abstracted from each trial.
Unlike the preponderance of past evidence examining the relationship between quality and effect size, the present study found that trials possessing the largest effect sizes within a meta-analysis were also associated with higher quality ratings than their counterparts possessing the lowest effect sizes (P=.019).
Possible theoretical reasons for this unexpected positive relationship include (a) sampling error, (b) reduced within group variation, (c) fraudulent reporting, and (d) the restriction of the analyses to placebo controlled trial.
在控制干预类型和结果变量的情况下,确定补充和替代医学(CAM)安慰剂对照随机对照试验(RCT)的质量是否与其产生的效应大小相关。
从MEDLINE和手工检索中确定了25项CAM荟萃分析样本,这些分析包含至少三项采用安慰剂对照组的疗效试验的已发表效应大小。从这25篇综述中,选择了26对试验:一对报告最大效应大小,另一对匹配试验报告最小效应大小。然后从每个试验中提取质量和发表特征。
与以往大多数研究质量与效应大小之间关系的证据不同,本研究发现,在荟萃分析中效应大小最大的试验,其质量评分也高于效应大小最低的试验(P = 0.019)。
这种意外的正相关关系可能的理论原因包括:(a)抽样误差;(b)组内变异减少;(c)虚假报告;(d)分析仅限于安慰剂对照试验。